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The thermometer is intended to measure human body temperature of people over one month from surface of forehead. It is a non-sterile, reusable, non-contact and hand-held device. It is indicated to be used in homecare and healtheare environments.

The Forehead thermometer is a handheld device, which can measure human body's temperature from the forehead for clinical or home use. The results can be displayed on LCD. The measurement is non-contact with a distance of 3-5 cm to measure the temperature. The thermometers are powered by AAA 1.5V×2 alkaline batteries, which can be used for people over one month. A thermopile sensor is employed to detect or monitor the infrared thermal energy emitted from the surface skin of the forehead, which is converted to a body temperature with the unit of °C or °F. The reference body site of the output temperature is oral. All the models share the similar design and the same critical components, and compose of a sensor, PCB, buttons, LCD display and housing. Functions include temperature measurement, memory reading recall, voice mute/unmute and unit/mode switch, low battery detection and high temperature indicator.

The provided text describes the acceptance criteria and a study demonstrating that the device meets these criteria. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size for Clinical Accuracy Validation:
  • AOJ-F101: 153 subjects
  • AOJ-F102: 142 subjects
  • AOJ-F103: 132 subjects
• Data Provenance: The document (K221170) is a 510(k) summary submitted to the FDA by a Chinese company (Shenzhen AOJ Medical Technology Co., Ltd. in Shenzhen, China). The clinical testing was explicitly stated as "Clinical accuracy validation was carried out on people over one month indicated in the instructions for use." While not explicitly stated, clinical studies for FDA submissions typically involve prospective data collection to demonstrate performance. The country of origin for the clinical data is not specified, but usually, it aligns with the manufacturer's location or regions where clinical trials are feasible and recognized for regulatory purposes.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. For a thermometer, "ground truth" for temperature is typically established using a highly accurate reference thermometer (e.g., a rectal thermometer for core body temperature, used in a clinical setting), rather than expert consensus on interpretation.

4. Adjudication method for the test set:

This information is not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments where multiple human readers interpret medical images or data. For a thermometer's accuracy, the ground truth is usually a precise measurement from a reference device, making such adjudication unnecessary.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. The device is a thermometer, a measurement tool, not an AI-assisted diagnostic device that aids human readers in interpreting complex cases. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device itself is a standalone measurement device. The "Clinical data" section describes a clinical accuracy validation study to confirm its performance directly against a clinical reference for body temperature, which is a form of standalone performance evaluation for a thermometer. There is no "algorithm only" in the context of an AI device here, but rather device-only performance for a physical product.

7. The type of ground truth used:

For the clinical accuracy validation, the ground truth for body temperature measurements would have been established using a highly accurate reference clinical thermometer (e.g., an oral or rectal thermometer, depending on the standard protocol for comparison) in a controlled clinical setting. The document specifies that clinical testing was conducted "per Section 201.102 of ISO 80601-2-56," which outlines the requirements for clinical investigations of medical electrical equipment used for body temperature measurement. This standard details how to establish accurate reference temperatures.

8. The sample size for the training set:

This information is not provided in the document. The document describes premarket testing and validation for a physical medical device, not a machine learning model that requires a training set. The "software verification and validation testing" refers to traditional software engineering V&V, not AI model training.

9. How the ground truth for the training set was established:

This information is not applicable as there is no mention of a training set for a machine learning model. The device is a conventional electronic thermometer.

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